Identifying resistance to CDK4/6 inhibitors in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect biological samples from women with ER-positive and HER2-negative metastatic breast cancer who are candidates for first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor. Patients will receive standard treatment while blood and tissue samples are collected at various time points for biomarker analysis, including thymidine kinase activity and circulating tumor DNA. The study seeks to understand primary resistance to these therapies by analyzing the collected samples over the course of treatment and disease progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Women aged 18 years or older, with a diagnosis of metastatic breast cancer
2. ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis
3. The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)
4. The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice
5. The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable).

   Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.
6. Hystologic material from one formalin-fixed, paraffin-embedded (FFPE) tumor block from a diagnostic core or excisional biopsy of a metastatic lesion, taken before study entry must be provided (patients with bone-only disease will be accepted into the trial without a biopsy of the metastatic site). Hystologic material from an additional biopsy (core or excisional) taken at time of disease progression on the study treatment must also be provided, if clinically feasible. When available, hystologic material from an FFPE tumor block from the primary breast cancer must also be submitted.
7. The patient agrees to provide blood samples. at the trial specified time points

Exclusion Criteria:

1. Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study.
2. Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and/or adequately treated basal cell or squamous cell carcinoma of the skin

Where it's running

• Hospital Santo Stefano
  Prato, Tuscany, Italy Recruiting

Study contacts

• Principal investigator: Luca Malorni — Azienda USL Toscana Centro - Prato
• Study coordinator: Luca Malorni
• Email: luca.malorni@uslcentro.toscana.it
• Phone: +390574802523

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.